scope:

General

This standard applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities.

NOTE-For purposes of this standard, "health care facilities" means hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term "hospital" is sometimes used in this recommended practice; in all instances, this term should be taken to encompass all other health care facilities.

Inclusions

This standard covers the design, performance, and labeling criteria for reusable rigid sterilization containers and instrument cases, cassettes, and organizing trays intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. Definitions of terms, normative references, and informative annexes are also included, as well as the rationale and relevant test methods for the provisions of the standard.

Exclusions

This standard does not cover the selection and use of containment devices by health care personnel.

NOTE-Guidelines for the selection and use of reusable rigid sterilization container systems in health care facilities are provided in ANSI/AAMI ST79.